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FDA approves first COVID-19 boosters targeting omicron variant

The boosters previously were being given under emergency use authorization.

Published: August 31, 2022 9:55am

Updated: August 31, 2022 10:17am

The Food and Drug Administration on Wednesday gave its first full authorization to a COVID-19 booster and said the original COVID vaccines may no longer be used as boosters for people over the age of 12. 

Moderna and Pfizer-BioNTech booster vaccines were previously being given under emergency-use authorization.

With the agency's announcement, Moderna's COVID booster vaccine is now authorized as a single booster dose for people over the age of 18. Pfizer's booster vaccine is now authorized for ages 12 and up.

The updated booster vaccines are bivalent, as they both include an mRNA component of the original COVID strain as well as an mRNA component that will provide better protection against the omicron variant, the Food and Drug Administration said. 

However, the original monovalent mRNA COVID vaccines, which millions of Americans have received since December 2020, are no longer authorized as booster doses for people ages 12 and up.

The agency said it will work "quickly to evaluate future data and submissions to support authorization of bivalent COVID-19 boosters for additional age groups."

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